West Expands Capabilities in Container Closure Integrity - HVLD
Integrity of a drug product container/delivery system is essential to guarantee safety and efficacy. USP has recently issued Chapter <1207> “Package Integrity Evaluation – Sterile Products”—a guidance for the pharmaceutical industry in measuring container closure integrity (CCI). In line with this guidance, West has just expanded its capability in measuring CCI by adding high-voltage leak detection (HVLD) –a method endorsed in Chapter <1207>.
HVLD operates by applying a high electrical potential to electrically conductive products inside package materials that are non- or semi-conductive, and sensing current flow resultant from a defect. The method has several advantages:
- Versatile: suitable for syringes, cartridges, and vials, whether composed of glass or plastic (e.g., Daikyo Crystal Zenith® cyclic olefin polymer)
- Specific: the position of a defect is displayed and recorded
- Convenient: measurement is rapid, and no special sample preparation is needed – it can be considered potentially for quality control
West scientists have validated HVLD in syringes with various solutions – protein (albumin - 100mg/mL), saline, Tween® 20, buffer, and sterile water for injection – with defects as small as 2 microns.
With the addition of HVLD, West has at its disposal several methods to measure CCI (along with helium leak, headspace analysis, vacuum decay, dye ingress). These methods not only support internal development, but reflect strong partnerships with customers to address their specific needs.
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Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.
Daikyo Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.
TWEEN is a registered trademark of Croda International PLC